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June 2016 Blog Posts (6)

A broad look at clinical research regulations

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that…

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Added by Adam Fleaming on June 10, 2016 at 3:16am — No Comments

What are the functions of computer system validation process?

Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:

  • Development of the system
  • Operation of the system
  • The system’s maintenance
  • Its retirement
  • Archiving…
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Added by Adam Fleaming on June 7, 2016 at 2:24am — No Comments

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

  • The US FDA
  • European Medicines Agency (EMA)
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices…
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Added by John Robinson on June 6, 2016 at 2:30am — No Comments

The emerging discipline of Hospitals Management Performance Assessments

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

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Added by Roger Steven on June 2, 2016 at 7:10am — No Comments

Implementation requirements of FDA's Bioresearch Monitoring Program

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483…

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Added by Adam Fleaming on June 2, 2016 at 3:08am — No Comments

It is important to ensure food safety in hospitals

It is important to ensure food safety in hospitals

Food-Services

Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…

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Added by Roger Steven on June 1, 2016 at 7:16am — No Comments

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Guidelines for Performing a Vendor Audit with an emphasis on Construction Audit at Training Doyens 26468 E Walker Dr,Aurora, Colorado

April 3, 2018 from 1pm to 2:30pm
OVERVIEWVendor/Contract audits require a certain skill set to understand the terms and conditions of a contract between a Company and any given vendor where products or services are outsourced.  Understanding the risks that are inherent within them is the first step in developing audit objectives and steps. The primary focus of the audit is the vendor (third party) activities pertinent to a contract. A majority of the fieldwork on these types of audits will likely be performed at the Vendor’s…See More
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How to begin your career in IBM API Connect? at 4608 Spalding, plano TX 75024 United States

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IBM API Connect is a complete API lifecycle management solution that will make things easier for developers, Central IT, and LoB Management. The thought behind API Connect is that APIs are small data applications, often called microservices, but they are applications nonetheless.IBM API Management with a built-in gateway, allowing you to create, run, manage, and secure APIs and Microservices. API Connect is the first of its kind: a unified end-to-end API management solution that enables the…See More
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Risk Management in the Global Economy and outlook for 2017

Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost becoming part of the global economy in this era of globalization; it is emerging that risks that apply to one part any one nation’s or group of…See More
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Hot Issues in Multi-State & Internet Sales Tax at 26468 E Walker Dr, Aurora, Colorado 80016-6104

March 13, 2018 from 1pm to 2pm
OVERVIEWStates are tense. They need more revenue.Millions of dollars of internet sales occur daily without tax.  The states want their money. In just 90 minutes, learn the different ways your company triggers nexus on itself and what it must do to comply with state regulations.WHY SHOULD YOU ATTENDWill I owe taxes in more than one state for the same sale? Must I charge tax on my internet sales?  Why is my drop shipper charging me tax?  Why did I receive a NEXUS Questionnaire and what if I don’t…See More
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Occupational Health and Safety 7 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tony Ferraro yesterday.

About sailpoint software

An identity management system refers to an information system, or to a set of technologies that can be used for enterprise or cross-network identity management. Additional terms are used synonymously…Continue

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Started by sujathayarlagadda on Friday.

What can be essentials safety measures taken to secure campus?

Students safety inside and outside the school premises is a huge concern in today's risk environment. what measures should be taken to ensure campus security?Continue

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Started by Jen McDade Feb 6.

What can be essentials safety measures taken to secure campus?

Students safety inside and outside the school premises is a huge concern in today's risk environment. what measures should be taken to ensure campus security?Continue

Tags: security, campus

Started by Jen McDade Feb 6.

What are the advantages of IoT in healthcare Industry?

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Started by Jen McDade Feb 5.

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